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Aluminum in Large and Small Volume Parenterals The Food and Drug Administration (FDA) is delaying until January 26, 2004, the effective date of a final rule published in the Federal Register of January 26, 2000, and originally scheduled to become effective on January 26, 2001 that requires disclosure of aluminum content in parenterals.
This has led to some confusion because some
companies have already started to comply with the labeling requirement by
disclosing the aluminum content while other companies do not yet disclose
this information. Some customers are concerned when they read the label, and
it states the product contains aluminum. As of January 26, 2004 all
companies will be required to state the aluminum content on their label.
The labeling disclosure has come about because
evidence has surfaced that links the use of parenteral drug products
containing aluminum to increased mortality of patients on total parenteral
nutrition (TPN) therapy, especially among premature babies and patients with
kidney problems.
Therefore, the FDA has added several
requirements for large-volume parenterals (LVPs), small-volume parenterals (SVPs),
and pharmacy bulk packages (PBPs) that contain aluminum and are used for TPN
therapy.
When drugs are administered orally, the
gastrointestinal tract prevents aluminum from being absorbed into a
patient's tissues. However, when drugs are administered parenterally,
aluminum can be deposited in tissues, potentially at toxic amounts.
Premature babies and patients with impaired kidney function were the two
groups in which research showed the greatest link between absorbed aluminum
and death.
Consequently, all LVPs used for TPN will no
longer be allowed to have more than 25 µg/L of aluminum. This includes
parenteral amino acid solutions, parenteral lipid emulsions, saline and
electrolyte solutions, highly concentrated dextrose solutions, and sterile
water for injection. In addition, the "Precautions" section of the labeling
of these LVPs must state that the aluminum limit is not exceeded.
For SVPs and PBPs, the maximum level of aluminum
at expiry must be noted on the immediate container label, using the phrase,
"Contains no more than (number) µg/L of aluminum." For lyophilized powders,
the wording must read, "When reconstituted in accordance with the package
insert instructions, the concentration of aluminum will be no more than
25mg/IL."
Unless the FDA delays the implementation date
again, effective January 26, 2004 all large-volume parenterals (LVPs),
small-volume parenterals (SVPs), and pharmacy bulk packages (PBPs) that are
used for TPN therapy will be required to state the aluminum content in the
product. |
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